Kelaprofen 100 mg, ketoprofen, Horses, cattle, pigs

KELAPROFEN 100 MG

Active substance:
Ketoprofen 100 mg;

Excipients:
Benzyl alcohol (E1519) 100 mg;
Clear, colorless or slightly yellowish solution.

Indications:
Horses:
–Relief of inflammation and pain associated with musculoskeletal disorders;
–Relief of visceral pain associated with colic.
Cattle:
–Supportive treatment of postpartum paresis;
–Reduction of pyrexia and distress associated with bacterial respiratory diseases, by use in combination with appropriate antimicrobial treatment;
–Improving the recovery rate in acute clinical mastitis, including acute endotoxin mastitis caused by gram–negative microorganisms with appropriate antimicrobial treatment:
–Reduction of udder edema associated with calving;
Swine:
–Reduction of pyrexia and high respiratory frequency associated with bacterial or viral respiratory diseases by use in combination with appropriate antimicrobial treatment;
–Supportive treatment in mastitis–metritis–agalaxia syndrome in sows, in combination with appropriate antimicrobial treatment.

Contraindications:
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not take with other nonsteroidal anti-inflammatory drugs (NSAIDs) concomitantly or within 24 hours of each other, as well as corticosteroids, diuretics, and anticoagulants.
Do not use in animals suffering from heart, liver or kidney disease, in which there is a possibility of gastrointestinal ulceration or bleeding, or in which there is evidence of blood dysphracy.

Side effects:
As with all NSAIDs, due to the action of inhibiting the synthesis of prostaglandins, there is the possibility of individual cases of gastric or renal intolerance. Allergic reactions can occur in very rare cases. If you notice any serious reactions or other effects that are not listed in this leaflet, please inform your veterinarian.

Target species:
Horses, cattle, pigs

DOSAGE FOR EACH SPECIES, ROUTE(S) OF ADMINISTRATION AND METHOD OF ADMINISTRATION
In the case of treating large groups of animals, the use of a dose withdrawal needle is recommended.
Do not puncture the container more than 33 times.

Horses:
Intravenous administration:
For use in musculoskeletal disorders:
2.2 mg ketoprofen/kg i.e. one ml of product per 45 kg of body weight, administered by intravenous injection once a day, for 3 to 5 days.
For use in colic in horses:
2.2 mg/kg (1 ml/45 kg) body weight, administered by intravenous injection for immediate effect. In case of recurrence of colic, a second injection may be administered.

Cattle:
Intravenous or intramuscular administration:
3 mg ketoprofen/kg body weight, i.e. one ml of product per 33 kg of body weight, administered by intravenous or deep intramuscular injection once a day for up to 3 days.

Swine:
Intramuscular administration:
3 mg ketoprofen/kg of body weight, i.e. 1 ml of product per 33 kg of body weight administered once a day by deep intramuscular injection.

WAITING TIME
Cattle:
Meat and organs:
-i.v.: 1 day;
-i.m.: 2 days;
-Milk: zero hours.
Horses:
Meat and offal: 1 day.
Milk: it is not authorised for use in lactating animals that produce milk for human consumption.
Swine:
Meat and offal: 2 days.

SPECIAL PRECAUTIONS FOR STORAGE
Keep out of reach of children;
Do not refrigerate or freeze;
Protect from light;
Do not use after the expiration date marked on the label;
The shelf life after the first opening of the container is 28 days;

SPECIAL WARNINGS
Special precautions for use in animals
It is not recommended to use ketoprofen in foals under 15 days of age.
Use in any animal under 6 weeks of age, or in old animals, may involve additional risks. If such use cannot be avoided, those animals may need a low dose and careful treatment management. Use in animals in a state of dehydration, hypovolaemia or hypotension should be avoided as this implies a potential risk of increased renal toxicity. Avoid intra–arterial injection.
Do not exceed the established dose and duration of treatment.

Special precautions to be taken by the person administering the product
Persons with known hypersensitivity to the active substance and/or benzyl alcohol should avoid contact with this veterinary medicinal product. In case of accidental self–injection, seek medical advice and present the product leaflet or label to the doctor. Wash your hands after use. Avoid splashing on the skin or eyes. If this happens, wash the affected area thoroughly with water. If the irritation persists, seek medical attention.

Use during pregnancy and lactation
The safety of the use of ketoprofen has been investigated in pregnant laboratory animals (rat, mouse and rabbit) and in pregnant cattle. Ketoprofen did not show teratogenic or embryotoxic effects. Ketoprofen can be administered to pregnant or lactating cattle. As the safety of the use of ketoprofen in pregnant sows has not been evaluated, the medicinal product should only be used in these cases following a risk/benefit assessment by the veterinarian. Do not use in pregnant women.

Interactions
Do not take with other nonsteroidal anti-inflammatory drugs (NSAIDs) concomitantly or within 24 hours of each other, as well as corticosteroids, diuretics, and anticoagulants.

Overdose
No clinical signs were observed for ketoprofen in horses at a dose 5 times the recommended dose for 15 days, in cattle at a dose 5 times the recommended dose for 15 days, in cattle at a dose 5 times higher than the recommended dose for 5 days, or in pigs at a dose 3 times higher than the recommended dose for 3 days.

Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other substances in the same syringe.

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR WASTE, AS APPROPRIATE
Medicines should not be disposed of in wastewater or household waste.

Presentation:
100 mg/ml glass container.